A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients

The objective of this study is to evaluate the safety and effectiveness of the VisAbility
Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This
is a prospective clinical study that will enroll and determine eligible a total of 360
subjects ranging in age between 45 and 60 years of age at up to 14 clinical sites. Subjects
will be implanted with the VisAbility Implant model SGP-046 in the primary eye and then in
the fellow eye no sooner than 14 days later. Subjects will be examined at one day, one week
and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.

The study will also include a 60 subject randomized controlled sub-study at 3 investigational
sites. Subjects enrolled and eligible at these sites will be randomized (1:1 ratio) to a
surgery group or a control group. Subjects randomized to the surgery group will undergo
surgery and will be followed for 24 months in the same manner as the larger non-randomized
surgical group. Subjects randomized to the control group will be followed for 6 months, and
will be eligible to undergo surgery after completion of this 6-month follow-up period.

The primary endpoint is achievement of distance corrected near visual acuity (DCNVA) of
Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in
DCNVA in the primary eye.

This endpoint will be evaluated against two objectives, a) 75% or more of primary eyes
achieve the effectiveness endpoint at 12 months postoperative and b) the percentage of
primary eyes achieving the effectiveness endpoint at 6 months postoperative (6-month
responder rate) is higher than the percentage in the randomized control group.

Inclusion Criteria:

- Subjects must have a Best Corrected Distance Visual Acuity (BCDVA) of 20/20 in each
eye

- Subjects must have a Distance Corrected Near Visual Acuity (DCNVA) @ 40 cm of 20/50,
20/63, or 20/80 in each eye

- Subjects must have an Uncorrected Near Visual Acuity (UCNVA) @ 40 cm of 20/50, 20/63,
or 20/80 in each eye

- Subject's Preoperative Manifest Refraction Spherical Equivalent (MRSE) in each eye
must be -0.75 to +0.50 diopters with no more than 1.00 diopter of astigmatism.

- Cycloplegic refraction spherical equivalent (CRSE) difference from MRSE should be less
than or equal to 0.50 diopters.

- Subjects must require a minimum add of +1.25 or greater to read 20/20 at near (40 cm).

- Subjects must be alert, mentally competent, and able to understand and comply with the
requirements of the clinical study, and be personally motivated to abide by the
requirements and restrictions of the clinical study. Patients must be available for
the follow-up period.

- Subjects must be able to provide written informed consent

Exclusion Criteria:

- Pupil has a baseline percent change from scotopic to photopic of less than 30% or an
absolute difference of less than 1.00 mm between scotopic and photopic pupil size as
measured by the NeurOptics Pupillometer

- Subjects with ocular inflammation, chronic uveitis, or other recurrent anterior or
posterior segment inflammatory conditions in either eye; subjects with any ocular or
systemic disease(s) posing a significant risk for ocular inflammation including but
not limited to, autoimmune disorders (e.g. rheumatoid arthritis, ankylosing
spondylitis, Reiter's syndrome, ulcerative colitis, Chron's disease, psoriasis,
sarcoidosis, Bechet's disease), infections (toxoplasmosis, cat-scratch fever, West
Nile virus, syphilis, tuberculosis, herpes zoster, herpes simplex, adenovirus), ocular
trauma or gout.

- Subjects with scleral thickness of less than 530 microns as measured 3.5 to 40.00 mm
posterior to the superior temporal quadrant limbus in either eye.

- Subjects with a history of any prior intraocular procedure (e.g. corneal transplant,
filtering procedures for glaucoma, vitrectomy, retinal detachment repair, cataract
surgery) or any prior refractive procedure (e.g. LASIK (laser in situ keratomileusis),
surface excimer, or incisional surgery) in either eye.

- Subjects with any history of prior extraocular muscle surgery or orbital surgery.

- Subjects with chronic ocular disease including but not limited to corneal pathology,
primary or secondary glaucoma, iritis, herpes simplex, uveitis, trachoma, ocular
pemphigoid, Sjogrens disease, uveal melanoma, Thyroid Related Immune Orbitopathy or
clinical significant retinal pathology in either eye.

- Subjects with any acute ocular disease that has not been completely treated and
resolved for at least three months such as conjunctivitis, blepharitis, chalazion,
corneal abrasion or keratitis in either eye.

- Subjects with chronic systemic diseases which may affect the eye, including but not
limited to diabetes, ulcerative colitis, systemic lupus erythematosus, Chron's
disease, collagen vascular disease, rheumatoid arthritis, any bleeding diathesis, or
systemic manifestations of HIV/AIDS. Any other uncontrolled systemic disease (e.g.
hypertension, cancer, etc.) that could compromise the patient's participation.

- Use of any medication such as Coumadin, that could make the surgical procedure more
difficult. Subjects using Coumadin, aspirin, or NSAID (non-steroidal anti inflammatory
drug) medications under orders from a doctor must be able to provide written approval
from the treating doctor for discontinuing this medication at least 10 days prior to
surgery.

- Subjects with chronic ocular surface disease, including but not limited to subjects
with a prior diagnosis of chronic dry eye syndrome based on tests such as but not
limited to, corneal or conjunctival staining, Ocular surface Disease Index symptom
score or Schirmer tear testing.

- Subjects who are allergic to any medications used in the protocol

- Subjects who are pregnant, lactating, or of child-bearing age adn not practicing a
medically approved method of birth control.